Roche Diagnostics Corporation recalls Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage:…

Recall date

December 17, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1146-2019

FDA classification

Class II

Brand / firm

Roche Diagnostics Corporation

Sold / distributed

US Nationwide distribution.

Why it was recalled

New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on cobas Integra for the quantitative determination of the lactate concentration in plasma and cerebrospinal fluid.